Breakthrough Device Designation: Understanding Regulatory and Reimbursement Implications Webinar

Moderator: Janet Trunzo
Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed

Janet E. Trunzo is Senior Advisor to the President and Senior Executive Vice President, Technology and Regulatory Affairs, for the Advanced Medical Technology Association (AdvaMed) and leads a team of regulatory experts. During her tenure at AdvaMed, she has focused on the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), its reauthorization in 2007, 2012, and 2017. She also concentrates on global regulatory harmonization and represents U.S. device industry on the APEC Regulatory Harmonization Steering Committee.  Trunzo also represents the device industry on the international Board of Trustees for the Global Medical Device Nomenclature Agency (GMDN) and chairs the Regulatory Committee for the Global Medical Technology Alliance (GMTA).  Prior to joining AdvaMed, Trunzo held positions at Hybritech, Inc., a medical device and diagnostics manufacturer, and Scripps Clinic and Research Foundation, a hospital, diagnostic clinic and research institute. Ms. Trunzo received her M.S. in health physics from Rutgers University and her B.S. in Chemistry from California University of Pennsylvania. 

Moderator: Chandra Branham, J.D., Vice President, Payment and Health Care Delivery Policy, AdvaMed

Chandra Branham, J.D., joined the Advanced Medical Technology Association (AdvaMed) as Vice President, Payment and Health Care Delivery Policy, in 2011.  Ms. Branham leads AdvaMed’s policy work in a number of areas, including diagnostics payment, coverage issues, value of medical technology and comparative effectiveness.  Prior to joining AdvaMed, Ms. Branham was an associate at large D.C. law firm where she focused on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services.  

Ms. Branham previously was a senior legislative analyst at the Centers for Medicare & Medicaid Services (CMS) Office of Legislation; and early in her career, served as associate director of regulatory affairs at the National Association for Home Care.  Ms. Branham has a Bachelor of Science from Drexel University and a J.D. from the George Mason University School of Law.  

Dr. Jeffrey Ballyns
Associate Director, Regulatory Policy, BD

Dr. Jeffrey Ballyns is an Associate Director of Regulatory Policy at Becton Dickinson and Company (BD). BD designs, manufactures, and sells a wide range of medical devices, including in vitro diagnostic (IVD) products worldwide. He is responsible for gathering, assessing, and communicating new regulatory policy requirements impacting BD businesses. Prior to working at BD, Dr. Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the US Food and Drug Administration for 8 years. While at the FDA, he served as a lead reviewer, Branch Chief and Division Director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. He was responsible for the pre-market review and post-market regulation of radiological imaging devices and artificial intelligence (AI) image analysis software applications. Dr. Ballyns received his bachelor’s and PhD degrees from Cornell University in Mechanical and Aerospace Engineering and Biomedical Engineering respectively.

Dr. James Kleinedler
Fellow, Regulatory Affairs, BSCI

Dr. James Kleinedler received his undergraduate degree in Chemical Engineering from Iowa State University, and then his Ph.D. in Toxicology from LSU Health Science Center, where he focused on cardiovascular combination products. Immediately after completing his graduate work, Dr. Kleinedler joined the FDA as a Biomedical Engineer in the Interventional Cardiology Devices Branch. During his tenure at FDA, James managed the review of Class II and Class III premarket device applications, product development protocols, investigational device exemptions (IDEs), and premarket notifications. Since 2014, Dr. Kleinedler has worked at Boston Scientific Corporation where he works as a Fellow in Regulatory Affairs and leads the company’s Emerging Therapy Team. In this role, he develops cohesive strategies for device commercialization that recognize shared needs across regulatory, clinical and reimbursement.

Dr. Tieuvi Nguyen
Director for the Division of Health Technology 1 A (Ophthalmic Devices)

Dr. Tieuvi Nguyen joined FDA in 2011 and currently serves as director of the Division of Ophthalmic Devices in CDRH. In this role, she oversees various scientific and regulatory policies related to the premarket approval, postmarket performance and surveillance, and compliance and enforcement of ophthalmic devices. Prior to joining the FDA, Nguyen held numerous positions in the pharmaceutical and finance industries. 

Ouided Rouabhi
Policy Analyst, FDA

Ouided Rouabhi serves as a Policy Analyst in FDA’s Center for Devices and Radiologic Health (CDRH) Office of Clinical Evidence and Analysis (OCEA). Her current role includes providing regulatory guidance to internal and external stakeholders regarding the interpretation and application of policies and procedures related to the Breakthrough Devices and IDE Programs. Prior to joining OCEA, Ouided served as a premarket reviewer in the Office of Cardiovascular Devices where she reviewed cardiac electrophysiology devices, and prior to this, in FDA’s Center for Tobacco Products, where she specialized in electronic cigarette research and policy. Ouided received her MS and BSE degrees in Biomedical Engineering from The University of Iowa.

Tamara Syrek Jensen, J.D.
Director of the Coverage and Analysis Group in the Centers for Clinical Standards and Quality, CMS

Tamara Syrek Jensen is the Director of the Coverage and Analysis Group in the Centers for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services (CMS).  CAG is responsible for developing evidence based policies such as national coverage determinations (NCDs).  In an effort to provide timely access to technologies that improve health outcomes for Medicare beneficiaries, Tamara leads the CMS collaboration with FDA, including the CMS-FDA parallel review program and the investigational device exemption (IDE) program.   To assist in generating evidence for the Medicare population, Tamara is one of the principal authors in creating and implementing coverage with evidence development (CED), an initiative that allows for Medicare coverage while developing evidence through clinical studies, including registries. 

Jon Waldstreicher
CEO, Gala Therapeutics

Jonathan Waldstreicher is a Partner at ATP and serves as CEO of Gala Therapeutics and Galaxy Medical.  He has worked in medical devices as an entrepreneur, investor, and clinician. Jon founded Gala to treat COPD after incubating the technology at ATP and spun Galaxy out of the platform to treat cardiac arrhythmias. Prior to joining ATP, Jon was a Director, Global Surgery R&D, at Johnson & Johnson. He started at Johnson & Johnson as an Associate Director in the Corporate Office of Science & Technology. Before medical school, Jon worked in Equity Research at Bear Stearns.

Jon received a BA from Brandeis University in economics and an MD and MBA from Tufts University School of Medicine. He completed a general surgery internship at Tufts Medical Center in Boston.